Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

NCT02335632 | Unknown Phase 4 DMC

• 1 other identifier: EPAH
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background/Aims: The investigators explored the therapeutic effects of probiotics in patients with AH. Methods: Between December 2012 and January 2015, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.

Conditions

Alcoholic Liver Disease

Keywords

Hepatitis; Probiotics; Lipopolysaccharides; Cytokines; Alcoholics

Outcome Measures

Primary Outcomes (1)

• liver enzymes

  7 days after probiotics

Secondary Outcomes (2)

• LPS and pro-inflammatory cytokines

  7 days after probiotics

• Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis

  7 days after probiotics

Study Arms (2)

Placebo

PLACEBO COMPARATOR

For Probiotics, 7 days

Drug: Placebo

Probiotics

ACTIVE COMPARATOR

Probiotics of 120 mg/day for 7days

Drug: Probiotics (Lacidofil®)

Interventions

Probiotics (Lacidofil®) DRUG

7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)

Also known as: Lacidofil®

Probiotics

Placebo DRUG

For probiotics

Also known as: For probiotics

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alcoholic hepatitis (AST/ALT \>2 \& elevated AST (ALT) level
• Alcohol \>60 g/day (M), \>40 g/day (F) during 7 days before screening
• Last drinks: within 48 hours prior to admission)

You may not qualify if:

• viral hepatitis,
• autoimmune hepatitis,
• pancreatitis,
• hemochromatosis,
• Wilson's disease,
• Drug-Induced Liver Injury,
• cancer,
• infection need for antibiotics,
• severe AH, or
• obesity (BMI \>30 kg/m2)

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Hepatitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Internal Medicine

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 12, 2015
• Study Start: December 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 28, 2015

Record last verified: 2015-01